Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension.
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension.
复制标题
人工智能干预临床试验方案指南：SPIRIT-AI扩展。
DOI：
10.1038/s41591-020-1037-7
复制
发表时间：
2020-09
期刊：
影响因子：
82.9
通讯作者：
SPIRIT-AI and CONSORT-AI Consensus Group
中科院分区：
文献类型：
--
作者：
Cruz Rivera S;Liu X;Chan AW;Denniston AK;Calvert MJ;SPIRIT-AI and CONSORT-AI Working Group;SPIRIT-AI and CONSORT-AI Steering Group;SPIRIT-AI and CONSORT-AI Consensus Group
SPIRIT 2013声明旨在通过为需要解决的最小项目集提供基于证据的建议来提高临床试验方案报告的完整性。这一指南有助于促进对新干预措施进行透明的评价。最近，人们越来越认识到，涉及人工智能（AI）的干预措施需要进行严格的前瞻性评估，以证明其对健康结果的影响。SPIRIT-AI（标准方案项目：人工智能干预试验建议）扩展是一项新的临床试验方案报告指南，用于评估人工智能组件的干预措施。它与试验报告的配套声明：CONSORT-AI（报告试验的综合标准-人工智能）同时开发。这两项准则都是通过一个分阶段的协商一致进程制定的，其中包括文献审查和专家咨询，以产生26个候选项目，这些项目在一个两阶段的德尔菲调查中由一个国际多方利益攸关方小组进行咨询（103个利益攸关方），在一次协商一致会议上达成一致（31个利益攸关方），并通过一个清单试点（34个参与者）加以完善。SPIRIT-AI扩展包括15个被认为对AI干预的临床试验方案足够重要的新项目。除了2013年SPIRIT核心项目外，还应定期报告这些新项目。SPIRIT-AI建议研究人员提供对人工智能干预的明确描述，包括使用所需的说明和技能，人工智能干预将被整合的环境，输入和输出数据处理的考虑因素，人机交互和错误案例分析。SPIRIT-AI将有助于提高人工智能干预临床试验方案的透明度和完整性。它的使用将有助于编辑和同行评审，以及一般读者，理解，解释和批判性地评估计划的临床试验的设计和偏倚风险。CONSORT-AI和SPIRIT-AI扩展提高了人工智能干预的临床试验设计和试验方案报告的透明度。
The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human–AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial. The CONSORT-AI and SPIRIT-AI extensions improve the transparency of clinical trial design and trial protocol reporting for artificial intelligence interventions.